Arm 1: temporally-modulated pulsed radiotherapy (TMPRT) for Astrocytoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Astrocytoma+4 More
temporally-modulated pulsed radiotherapy (TMPRT) - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.

Eligible Conditions

  • Astrocytoma
  • Oligodendroglioma, Adult
  • Gliomas, Malignant

Treatment Effectiveness

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: At one year after start of treatment

Month 12
Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)
Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Week 6
Relative changes of different subtypes of circulating T-cells
Relative changes of different subtypes of myeloid cells
At one year after start of treatment
Overall survival (OS)
Progression-free survival (PFS)
Year 1
Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
Month 3
Frequency of intolerable toxicities

Trial Safety

Trial Design

1 Treatment Group

Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT) · No Placebo Group · N/A

Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)
Radiation
Experimental Group · 1 Intervention: temporally-modulated pulsed radiotherapy (TMPRT) · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at one year after start of treatment
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine  1Photo of washington university school of medicine  2Photo of washington university school of medicine  3
2004First Recorded Clinical Trial
22 TrialsResearching Astrocytoma
1465 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy
The cumulative dose of EBRT plus SRS is no more than 75 Gy
You must be over 12 months old.
You are at least 18 years of age.
You are able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.